Quality Assurance Expert - Computerized Systems (M/F)

JR France; Paris; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading consulting group is seeking a Quality Assurance Expert for Computerized Systems in Paris. The role involves ensuring compliance with regulatory standards, overseeing validation strategies, and collaborating with teams in a prestigious pharmaceutical group. Candidates should have a Master's degree and extensive experience in Computerized Systems Validation. Join a vibrant team committed to innovation and patient benefit.

Qualifications

• Minimum 3 years of experience in Computerized Systems Validation.
• Experience in the pharmaceutical and clinical research sectors.

Responsabilités

• Ensure compliance with GxP requirements and validation strategies.
• Oversee outsourced validation activities and define tasks.
• Conduct training on computerized system validation.

Connaissances

Analytical Skills

Problem Solving

Communication

Interpersonal Skills

Formation

Master’s degree in Life Sciences

Master’s degree in Pharmaceutical Sciences

Description du poste

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Quality Assurance Expert - Computerized Systems (M/F), Paris

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Client:

Gi Group Holding

Location:

Paris, France

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

36192808505599590432761

Job Views:

2

Posted:

16.05.2025

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Job Description:

Gi Group Consulting is an international consulting group, reporting a turnover of €2.84 million and a growth rate of 25%. As a family-owned company specializing in talent placement within the healthcare industry, we place human values at the heart of our mission. We leverage our expertise in Life Sciences to serve our clients: pharmaceutical companies, CROs, and biotech firms.

We are recruiting in Saclay a Quality Assurance Expert - Computerized Systems (M/F) for a mission within a prestigious pharmaceutical group starting in June 2025. Our client is an international pharmaceutical laboratory committed to therapeutic progress for the benefit of patients, in collaboration with healthcare professionals. Its growth is based on a constant search for innovation across multiple therapeutic areas.

We are looking for a dedicated and detail-oriented professional with extensive experience in Computerized Systems Validation within Clinical Development, Pharmacovigilance, and Regulatory Affairs. Seeking to leverage expertise in ensuring compliance with GxP, GAMP 5, and 21 CFR Part 11 standards. Committed to implementing risk-based validation strategies, overseeing outsourced activities, and providing guidance on validation management.

Responsibilities

• Ensure Computerized System Validation is performed in compliance with corporate policy and procedures, and regulatory GxP requirements. In particular, define validation strategies, review ongoing or existing documentation, and ensure correct management of dysfunctions.
• Implement and maintain computerized systems compliance according to applicable standards.
• Lead the computerized system validation strategy following a risk-based approach considering the potential impact on human subject safety, data protection, product quality, and result reliability.
• Oversee outsourced validation activities: define tasks/activities to subcontract, review/approve key validation deliverables, and ensure compliance with procedures and guidelines.
• Advise, guide, and support relevant teams in validation management.
• Conduct training on computerized system validation.
• Perform initial risk assessments and periodic reviews of computerized systems.
• Participate in audits of IT systems and suppliers, and in inspection preparations and responses.
• Implement Corrective and Preventive Actions (CAPA) as needed.
• Assess the impact of regulatory changes on validation practices.

Profile

• Minimum 3 years of experience in Computerized Systems Validation within the pharmaceutical and clinical research sectors.
• Master’s degree in Life Sciences, Pharmaceutical Sciences, or related fields.
• Strong analytical and problem-solving skills for risk assessments and validation strategies.
• Excellent communication skills for interactions with teams, stakeholders, and regulatory bodies, including training and mentoring.
• Strong interpersonal skills and a collaborative approach to ensure compliance and validation across departments.

Are you looking to be part of a vibrant and ambitious team?

Does this position resonate with your skills and aspirations?

If so, we’d love to hear from you—don’t wait, apply today!